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NCT03197922 · ClinicalTrials.gov registry record · Phase 3
Treatment of Encopresis in Children With Autism Spectrum Disorders
A Phase 3 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 3
- Development phase
- 117
- Enrollment target
NCT03197922: Completed Phase 3 study, sponsored by Emory University.
NCT03197922 is a Phase 3 study that has completed, run by Emory University. The registered enrollment target is 117 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03197922, a Phase 3 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 117 participants
- Enrollment target
Study Summary
This study is comparing a multidisciplinary intervention for encopresis (MIE), consisting of both medical and behavioral components to treatment as usual control (TAU). Participants are first screened by a pediatric gastroenterologist and assessed and treated for any constipation or other potential medical complications. Following this, caregivers collect data on bowel movements and continence during a home baseline lasting no less than 14 days and no more than 21 days. Participants randomly assigned to treatment as usual or the treatment group, and begin attending daily appointments in clinic for 2 weeks. At appointments, the behavior team implements structured sits on the toilet to promote independent bowel movements (BMs). If an independent BM does not occur, the study team will administer a suppository to promote rapid release of the bowels and prompt the child to remain on the toilet following administration. In doing so, continent bowel movements are predictably evoked while the child is on the toilet, allowing for reinforcement with praise and preferred toys/activities. Eventually, suppositories are gradually decreased until the child is having BMs independently. Caregivers are trained to continue implementing the intervention following the clinic-based portion. The purpose of the current study is to evaluate MIE using a large randomized clinical trial (RCT), addressing the Department of Defense Autism Research Program, Area of Interest of Therapies to Alleviate Conditions Co-Occurring with autism spectrum disorder (ASD). The researchers will recruit 112 children diagnosed with ASD, randomizing them to two weeks of MIE, or treatment as usual (TAU) consisting of behavioral consultation and medical intervention. This study will evaluate MIE compared to TAU and determine the optimal treatment length.
Primary Outcome
The percentage to continent bowel movements, based on parent report during the prior 7 day period, are reported for Baseline and the end of treatment at Week 8.
Interventions
- DRUG Glycerin Suppository
- BEHAVIORAL MIE Treatment
- COMBINATION_PRODUCT Treatment as Usual (TAU)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2017-10-25 |
| Est. Completion | 2022-11-17 |
| Phase | Phase 3 |
What the finished NCT03197922 record still lists
NCT03197922 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Glycerin Suppository is the first listed.
NCT03197922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03197922 about?
NCT03197922 is a clinical study titled "Treatment of Encopresis in Children With Autism Spectrum Disorders". This study is comparing a multidisciplinary intervention for encopresis (MIE), consisting of both medical and behavioral components to treatment as usual control (TAU). Participants are first screened by a pediatric gastroenterologist and assessed and treated for any constipation or other potential ...
What is the current status of trial NCT03197922?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2017-10-25. Estimated completion is 2022-11-17.
What interventions are being tested in trial NCT03197922?
The interventions under investigation include: Glycerin Suppository (DRUG), MIE Treatment (BEHAVIORAL), Treatment as Usual (TAU) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03197922?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03197922's enrollment target sits among peer trials
117 1642nd of 2000 higher than 358 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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